Metabolomics Explores Biomarkers for Metastatic Breast Cancer
Clinical Study of Metabolomics-based Approach Explore Biomarkers for Metastatic Breast Cancer
1 other identifier
observational
500
1 country
1
Brief Summary
RATIONALE: Studying samples of plasm by metabolomics-based approach from women with metastasis breast cancer may help doctors understand the biomarker of visceral metastasis. PURPOSE: This clinical trial is studying the biomarker of visceral metastasis by metabolomics approach in metastasis breast cancer undergoing treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 3, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedMarch 10, 2020
March 1, 2020
5 months
March 3, 2020
March 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metabolites changes of plasma by High Performance Liquid Chromatography-Mass Spectrometry (LC-MS).
To assess the changes of metabolites during the process of our observation, and to find out the relationship between metabolite(s) and therapeutic effect.
up to six months
Secondary Outcomes (2)
progression of disease
Up to 10 years
overall survival
Up to 10 years
Study Arms (5)
only liver metastasis
There is no other intervention, only clinical treatment.
only lung metastasis
There is no other intervention, only clinical treatment.
only brain
There is no other intervention, only clinical treatment.
No distant metastasis
There is no other intervention, only clinical treatment.
More than two organs metastasis
There is no other intervention, only clinical treatment.
Interventions
There is no other intervention, only clinical treatment.
Eligibility Criteria
Patients must have histologically or imaging confirmed breast cancer with visceral metastatic.
You may qualify if:
- Age: 18-70 yrs.
- Any menopausal status.
- Any hormone receptor status.
- Patients must have histologically or imaging confirmed breast cancer with visceral metastatic.
- Patients must have measurable disease, per RECIST criteria v1.1.21.
- Estimated life expectancy of ≥ 12 weeks.
- Ability to swallow oral medications.
- Participants must have adequate organ function as defined by:
- ANC ≥1.5 x 109/L, platelet count ≥100 x 109/L, haemoglobin ≥ 10 g/dL.
- creatinine \< 1.5 x UNL (upper normal limit).
- Total bilirubin \< 1.5x UNL.
- ALT \& AST \< 2.5xUNL; alkaline phosphatase \< 2.5xUNL.
- Creatine phosphokinase (CPK) ≤ 2.5 x UNL.
- Patients with CNS metastatic disease are allowed if the disease is controlled and stable for at least 3 months by CT or MRI.
You may not qualify if:
- Current severe, uncontrolled systemic disease (e.g. pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).
- History of other malignancies.
- No measureable lesion is present, as defined by RECIST 1.1.
- Patients who suffer from a medical or psychiatric condition that, in the opinion of the principal investigator, would impair their ability to participate in the study.
- Concurrent interventional studies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Biospecimen
plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
YU Zhiyong, PhD
Shandong Cancer Hospital and Institute
- PRINCIPAL INVESTIGATOR
WANG Fukai, MM
Shandong Cancer Hospital and Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Breast surgery
Study Record Dates
First Submitted
March 3, 2020
First Posted
March 10, 2020
Study Start
October 1, 2019
Primary Completion
March 1, 2020
Study Completion
February 1, 2023
Last Updated
March 10, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share